Industry news

• Logisticians offer resources to producers for the storage of stocks

  06 June 2022 GxPnews

  NC Logistic has completed the validation and qualification of a 2500-pallet cold storage chamber with a temperature regime of +2…+8 °C. The chamber has been put into operation and is intended for medicines and vaccines storage.

• How can X-ray irradiation advance pharmaceutical sterilisation?

  03 June 2022 Hannah Balfour / European Pharmaceutical Review

  Among several alternative methods, X-ray irradiation is being considered as a potential pharmaceutical sterilisation process. Here, EPR summarises the salient points of a paper exploring why.

• Early phase CGT trials: key design elements correlating to distinctive biological characteristics

  03 June 2022 European Pharmaceutical Review

  With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.

• How to overcome imported APIs dependence

  02 June 2022 GxPnews

  Since the 1990s, China has become a global monopolist in the production of pharmaceutical substances; the country exports 3 million tons of APIs and intermediates annually. As in most countries of the world, the pharmaceutical industry in Russia uses mainly Chinese substances. We depend on them for half of our raw materials: we buy more than 250 APIs in China, and 60 of them are unique and cannot be procured anywhere else. 

• Only joint efforts can improve the quality and accessibility of cancer care in our country

  02 June 2022 GxPnews

  “Zdravstvuy!” (“Hello!”) is the name of the All-Russian Association of Cancer Patients, which has been helping people diagnosed with cancer for five years.

• NEWS TOC sampling error could be impacting cleaning verification

  01 June 2022 BioPharm International

  Study finds several variables can significantly increase the sampling error in total organic carbon (TOC) swab testing used for pharmaceutical cleaning verification.

• FDA Stresses Risk Management Plans

  01 June 2022 BioPharm International

  Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research (CDER), issued a statement on May 19, 2022 announcing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, to help drug manufacturers develop, implement, and maintain risk management plans. The new guidance is part of the agency’s effort to address disruptions in manufacturing which cause drug shortages.

• New Guidelines Aim to Advance Pediatric Drug Development

  31 May 2022 BioPharm International

  A new framework for extrapolating clinical trial data from adult studies seeks to facilitate the testing and approval of therapies for children more quickly and at less cost. The process for achieving such gains is presented in a draft guideline recently released by the International Council for Harmonisation (ICH) that maps out common methods and strategies for identifying how development programs for adult drugs can inform pediatric indications. 

• Three Key Steps to Unlocking mRNA’s Potential Beyond COVID-19

  31 May 2022 Sadik Kassim / Pharmaceutical Executive

  Although mRNA was thrust into the spotlight by COVID-19, the potential for this emerging therapeutic modality extends far beyond the vaccines that were developed in record time during the pandemic. The second wave of mRNA could usher in preventative vaccines for the flu and a wide range of bacterial and fungal diseases. Some drug developers are working on personalized mRNA vaccines that fight cancer based on genetic mutations found in individual patients’ tumors.

• Surface roughness key to microbial control

  30 May 2022 Hannah Balfour / European Pharmaceutical Review

  In a recent paper, pharmaceutical microbiologist and contamination control expert Tim Sandle explored the critical role surface roughness can play in preventing microbial attachment. Here, EPR summarises the salient points.